There is no evidence that high levels of total cholesterol or of “bad” cholesterol cause heart disease, according to a new paper by 17 international physicians based on a review of patient data of almost 1.3 million people.
The authors also say their review shows the use of statins – cholesterol lowering drugs – is “of doubtful benefit” when used as primary prevention of cardiovascular disease.
The authors include Galway-based Prof Sherif Sultan, professor of the International Society for Vascular Surgery; Scottish-based Dr Malcolm Kendrick, author of The Great Cholesterol Con; and Dr David M Diamond, a US-based neuroscientist and cardiovascular disease researcher.
Prof Sultan said millions of people all over the world, including many with no history of heart disease, are taking statins “despite unproven benefits and serious side effects”.
He was also concerned that inhibitors to further lower LDL cholesterol (LDL-C), referred to as “bad” cholesterol, are being promoted. The cost of that medication is about €20,000 annually, he said.
“We suggest that clinicians should abandon the use of statins and PCSK-9 inhibitors, and instead identify and target the actual causes of cardiovascular disease.”
The paper disputes recommendations in a number of reviews of statin use and claims those are “based on misleading statistics, exclusion of unsuccessful trials and ignoring numerous contradictory observations”.
The paper is published online this week in the Expert Review of Clinical Pharmacology journal.
Prof Sultan said it involved a comprehensive review of patient-level data of 1,291,317 individuals across existing trials with a view to answering a number of questions including whether LDL-C causes cardiovascular disease.
The paper says high “bad” cholesterol levels appear to be unrelated to the risk of disease, both in individuals with familial hypercholesterolemia (a genetic disorder characterised by high LDL-C levels) and in the general population, he said.
The authors say their review of the data from existing trials showed the benefit from the use of cholesterol-lowering drugs is “questionable”.
They found no association between high total cholesterol and atherosclerosis (hardening of the arteries) and noted four studies had confirmed lack of an association between LDL-C and atherosclerosis.
They found patients with acute myocardial infarction had lower than normal “bad” cholesterol and that healthy individuals with low “bad” cholesterol have a “significantly increased” risk of infectious diseases and cancer.
The “strongest finding” was that elderly people with high LDL-C live the longest, Prof Sultan said.
On the issue of whether cholesterol-lowering treatment lowers the risk of cardiovascular disease, the paper said claims of benefit from statin trials have "virtually disappeared" since new regulations introduced in 2005 by health authorities in Europe and the US specified that all trial data had to be made public.
The authors examined whether the risk of disease fell following the use of statins and concluded statin use in 12 European countries between 2000 and 2012 was not associated with reduced mortality.
The hypothesis that high total cholesterol or LDL-C causes atherosclerosis and disease “has been shown to be false”, they said.
They conclude that high “bad” cholesterol is beneficial in terms of overall lifespan.
They also conclude statin treatment has many serious side effects and claim that these have been “minimised” by certain trials.